New Head-to-Head Phase 3 Study Evaluated Systolic Blood Pressure Reduction of Investigational Compound Azilsartan Medoxomil Compared to Valsartan
Data from comparator trial presented at the European Society of Hypertension (ESH) Annual Scientific Meeting
DEERFIELD, Ill., June 21, 2010 /PRNewswire/ -- Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) today announced results from a pivotal phase 3 study of azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) that demonstrated greater 24-hour mean systolic blood pressure (SBP) and clinic SBP reduction at 24 weeks compared to the commonly prescribed ARB, valsartan. Results showed that azilsartan medoxomil (40 mg/day and 80 mg/day) lowered 24-hour mean SBP by Ambulatory Blood Pressure Monitoring (ABPM), the primary endpoint, and clinic SBP in a head-to-head trial with the highest approved dose of valsartan (320 mg/day) in hypertensive patients. The study results were statistically significant and were presented at the European Society of Hypertension Annual Scientific Meeting, in Oslo, Norway.
"Controlling hypertension continues to be a serious problem with more than half of these patients not achieving their blood pressure goals," said Domenic Sica, M.D., lead investigator, and professor of Internal Medicine and Nephrology at Virginia Commonwealth University Medical Center. "We were encouraged by the findings, which demonstrated greater blood pressure reduction seen in patients treated with azilsartan medoxomil compared to valsartan, and believe that the compound, if approved, could potentially be an important new treatment option to help patients control their hypertension."
The azilsartan medoxomil New Drug Application was submitted to the U.S. Food and Drug Administration in April 2010 and was supported by seven phase 3 clinical trials involving more than 5,900 patients. The most commonly reported treatment-related adverse reactions (>/= 1%) in phase 3 clinical trials were dizziness (2.1%), increased blood creatine phosphokinase (1.1%) and diarrhea (1.0%).
This phase 3 randomized, double-blind study evaluated change in 24-hour mean SBP by ABPM of azilsartan medoxomil as compared to valsartan. Secondary efficacy endpoints included clinic trough blood pressure measurements. During the 24-week trial, 982 patients were randomized and force-titrated to treatment with either azilsartan medoxomil 40 mg/day (n=327), 80 mg/day (n=329) or valsartan 320 mg/day (n=326). Patients' mean age was 58 years and 52 percent were men.
At 24 weeks, azilsartan medoxomil 40 mg/day and 80 mg/day lowered 24-hour mean SBP by ABPM by 14.9 mm Hg and 15.3 mm Hg, from baseline respectively. The reductions were statistically significantly greater than those observed with valsartan 320 mg/day (11.3 mm Hg). Also at 24 weeks, azilsartan medoxomil 40 mg/day and 80 mg/day lowered SBP by clinic trough blood pressure measurement by 14.9 mm Hg and 16.9 mm Hg, from baseline respectively. The reductions were statistically significantly greater than those observed with valsartan 320 mg/day (11.6 mm Hg).
High blood pressure, or hypertension, impacts approximately 75 million Americans and is the second-leading preventable risk factor for death in the U.S. Hypertension is defined as elevated blood pressure 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. Approximately 56 percent of all hypertension patients, or approximately 42 million Americans, still have uncontrolled hypertension despite current treatment options, or due to a lack of being diagnosed or treated. Hypertension can lead to serious or fatal health problems. High blood pressure often has no warning signs or symptoms, and many people don't realize they have it. People of all ages and backgrounds can develop hypertension, and the National Heart, Lung, and Blood Institute recommends blood pressure be checked every two years and that people with hypertension should check their blood pressure levels several times a year.
Discovered by Takeda, azilsartan medoxomil, also known as TAK-491, is an angiotensin II receptor blocker currently in development for the treatment of hypertension, or high blood pressure, either used alone or in combination with other classes of antihypertensive agents. Angiotensin II, a vasopressor, is a hormone that naturally exists within the body and plays a key role in cardiovascular function. The hormone induces contraction, or tightening, of blood vessels and thus plays an important role in mediating hypertension. The most commonly reported treatment-related adverse reactions (>/= 1%) in phase 3 clinical trials were dizziness (2.1%), increased blood creatine phosphokinase (1.1%) and diarrhea (1.0%).
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.
Contacts: Jaimee Lumm Elissa J. Johnsen GolinHarris Takeda Pharmaceuticals North America 312-729-4276 224-554-3185 firstname.lastname@example.org email@example.com Josephine Zammuto Takeda Global Research & Development 847-582-5971 firstname.lastname@example.org
CONTACT: Josephine Zammuto of Takeda Global Research & Development,+1-847-582-5971, ; or Elissa J. Johnsen of TakedaPharmaceuticals North America, +1-224-554-3185, ; orJaimee Lumm of GolinHarris, +1-312-729-4276, , forTakeda Global Research & Development email@example.com firstname.lastname@example.org email@example.com
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Posted: June 2010